Prevalence of Periodontitis in Patients With Plaque Psoriasis. A Cross-sectional Study

NCT04722094 | Unknown

• 1 other identifier: PSO001
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

Psoriasis is a chronic inflammatory disease with a multi-factorial etiology which affects the epidermis and dermis. It affects around 1-3% of the general population and its most frequent form is plaque psoriasis (around 80-90% of the overall psoriasis cases). Psoriasis severity and extension are usually measured through 2 scores: Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA). Periodontitis is a chronic inflammatory disease mediated by the biofilm and with a multi-factorial etiology. Its manifestation entails the destruction of the periodontal tissues surrounding the teeth; the final stage of disease is characterised by tooth loss. Periodontitis severity and extension are usually evaluated through surrogate variables such as: BoP (Bleeding on Probing), PPD (Probing Pocket Depth) e REC (Recession). Both diseases present overlapping genetic and pathophysiologic features, as well as common risk factors (e.g. genetic polymorphisms, smoking habit, obesity, diabetes etc.). miRNAs are small non-coding molecules involved in the regulation of various biologic processes thanks to their interaction with mRNAs. Active inflammatory processes either in the oral cavity or at a systemic level tend to alter the concentration of salivary miRNAs. No study so far has ever profiled the levels of specific salivary miRNAs in patients with psoriasis and periodontitis. Some case-control studies highlighted a higher prevalence of periodontitis in patients with psoriasis when compared to healthy controls. Nonetheless, epidemiological data regarding periodontitis prevalence in patients with psoriasis are lacking; moreover, few data are available regarding the relationship between the severity of psoriasis and the severity of periodontitis, together with the effect of common risk factors (e.g. diet, obesity, physical activity, sleep quality etc.).

Conditions

Psoriasis; Plaque Psoriasis; Periodontal Diseases; Periodontitis

Outcome Measures

Primary Outcomes (1)

• Prevalence of Periodontitis in patients with Plaque psoriasis

  The prevalence of patients with a diagnosis of periodontitis among the included cohort will be measured.

  Baseline

Secondary Outcomes (1)

• relationship between salivary miRNAs concentration and the severity of psoriasis and periodontitis

  Baseline

Study Arms (1)

Patients with Psoriasis

All patients pertaining to the Unit of Dermatology and affected by psoriasis will be screened for the inclusion in the study

Diagnostic Test: Full periodontal chart; Other: Saliva sampling

Interventions

Full periodontal chart DIAGNOSTIC_TEST

A full periodontal chart will be carried out including all biometric periodontal variables: Probing Pocket Depth (PPD), Bleeding on Probing (BoP), presence of Plaque, recession (REC), Full Mouth Plaque Score (FMPS), Full Mouth Bleeding Score (FMBS), presence of furcation and mobility. Periodontal status, as assessed by the periodontal chart, will be evaluated following the New Classification of Periodontal and Peri implant diseases.

Patients with Psoriasis

Saliva sampling OTHER

Saliva samples for miRNAs detection will be taken before starting the visit.

Patients with Psoriasis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients affected by Plaque Psoriasis and meeting the inclusion criteria will be screened for the inclusion in the present study.

You may qualify if:

• Age between 18 and 70 years old
• Diagnosis of plaque psoriasis
• Ability and willingness to give informed consent

You may not qualify if:

• Inability of unwillingness to give informed consent
• Pregnancy or lactation

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

AOUS

Siena, 53100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva sample for miRNAs extraction (miRNAs 146a, 155, 223, 21)

MeSH Terms

Conditions

Psoriasis; Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Nicola Discepoli, DDS, MsC, PhD

  University of Siena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Discepoli, DDS, MsC, PhD

CONTACT

0577 585772; nicola.discepoli2@unisi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 25, 2021
• Study Start: January 25, 2021
• Primary Completion: June 25, 2021
• Study Completion: August 25, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)